Article
ASCORE, a 2-Year, Observational, Prospective Study of Subcutaneous Abatacept for Rheumatoid Arthritis in Clinical Practice: Baseline Characteristics of the German Cohort
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Authors
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Rieke H.-E. Alten
- Schlossparkklinik, Akademisches Lehrkrankenhaus der Charité - Universitätsmedizin Berlin, Innere Medizin II, Rheumatologie, klinische Immunologie und Osteologie, Berlin
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Hubert Nüßlein
- University of Erlangen-Nuremberg, Nuremberg
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Manuela Le Bars
- Bristol-Myers Squibb, Rueil-Malmaison, France
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C. Chauvet
- DOCS, Nanterre, France
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Julia Heitzmann
- Excelya, Boulogne-Billancourt, France
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Christiane Rauch
- Bristol-Myers Squibb GmbH & Co. KGaA, München
| Published: | September 4, 2017 |
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Outline
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Background: ASCORE (Abatacept SubCutaneOus in Routine clinical practicE; NCT02090556) is an ongoing, 2-year, prospective, non-interventional, multicentre study of patients with RA receiving SC abatacept across 11 countries. The key primary objective is to estimate the overall 2-year retention rate for SC abatacept in routine clinical practice. To provide a local perspective, baseline characteristics are described for the German cohort.
Methods: Patients (≥18 years) with active, moderate-to-severe RA who initiated SC abatacept 125 mg weekly for ≥1 month were enrolled into ASCORE between March 2013 and December 2016. The inclusion period for patients in Germany was 26 March 2013 (first patient, first visit) to 3 September 2015 (last patient, first visit). The patient demographics and disease characteristics at initiation of SC abatacept administered using the syringe device were recorded for patients enrolled in the German cohort.
Results: Of the 2846 patients enrolled in ASCORE, 683 were enrolled in Germany; 652/683 (96%) were included in the analysis population. All patients in the German cohort initiated SC abatacept using the syringe device. Baseline patient and disease characteristics of this population are shown in the Table 1 [Tab. 1]. Mean (SD) disease duration was 12.6 (9.5) years; 212/417 (51%) patients had received 1 and 205/417 (49%) patients had received ≥2 previous anti-TNFs. BMI was available for 643 patients: 235/643 (37%) had BMI <25 kg/m² (underweight/normal); 231/643 (36%) had BMI 25–<30 kg/m² (overweight); and 177/643 (28%) had BMI ≥30 kg/m² (obese). In the German cohort, 374/594 (63%) patients were single RF positive (+) and 374/557 (67%) were single anti-cyclic citrullinated peptide (anti-CCP)+; 297/625 (48%) patients were double RF+/anti-CCP+ and 134/625 (21%) were double RF/anti-CCP negative. In the German cohort, 261/439 (60%) patients had radiographic erosions at baseline; mean (SD) DAS28 (CRP), TJC28 and SJC28 were 4.6 (1.2), 8.1 (6.5) and 5.4 (4.9), respectively. 73/631 (12%) patients initiated abatacept with MTX alone and 399/631 (63%) patients initiated abatacept with MTX plus another conventional synthetic DMARD (csDMARD); 159/631 (25%) patients initiated abatacept with a csDMARD other than MTX.[IMG1]
Conclusion: Most patients in the German cohort of ASCORE had established RA (≥6 years). The majority initiated SC abatacept combined with MTX ± another csDMARD; however, one in four patients initiated SC abatacept with a non-MTX csDMARD.
